Pyrocarbon Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemiarthroplasty with pyrocarbon, Anatomic total shoulder arthroplasty.
- Who it may be relevant to
- Registry conditions: Glenohumeral Osteoarthritis. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hemiarthroplasty Versus Total Shoulder Arthroplasty for the Treatment of Glenohumeral Osteoarthritis: The Impact of Modern Implant Options
Overview
This is a multi-center study assessing postoperative outcomes associated with hemiarthroplasty with pyrocarbon (hPYC) versus anatomic total shoulder arthroplasty (aTSA). Once eligibility criteria is met, the subject will be randomized to one of the two study arms. Subjects will be followed for ten years. Clinical and patient-reported outcome measures (PROMs) will be assessed.
Interventions
- Device Hemiarthroplasty with pyrocarbon
Hemiarthroplasty with pyrocarbon - Device Anatomic total shoulder arthroplasty
Anatomic total shoulder arthroplasty
Primary outcome measures
- Single Assessment Numeric Evaluation score [Time frame: 2-years]
Secondary outcome measures (6)
- American Shoulder and Elbow Visual Analog Pain Score [Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years]
- Forgotten Joint score [Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years]
- Range of motion [Time frame: 2-weeks, 3-months, 6-months, 1-year, 2-years, 5-years, 10-years]
- Assess rates of glenoid erosion [Time frame: 2-years, 5-years, 10-years]
- Assess rates of aseptic glenoid loosening [Time frame: 2-years, 5-years, 10-years]
- Single Assessment Numeric Evaluation Score [Time frame: 5-years, 10-years]
Eligibility criteria
Inclusion criteria
- Fluent in English language
- Willing to sign an informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Age 40 to 65 years
- In good general health as evidenced by medical history
- Surgical indication of glenohumeral osteoarthritis 7. In the opinion of the surgeon, there is clinical equipoise for the subject to be implanted with a humeral hemiarthroplasty with pyrocarbon or anatomic total shoulder arthroplasty
Exclusion criteria
- Presence of Walch Type C or D glenoid
- Presence of a glenoid that could not be reconstructed with the anatomic glenoid resurfacing components
- Presence of extreme preoperative glenoid deformity including uniplanar retroversion deformity >30 o or severe biplanar deformity (retroversion >20 o and inclination > 10 o).
- Workers' compensation case
- Presence of full-thickness rotator cuff tear
- Known allergic reactions to components of the study product(s)
- History of consistent narcotic use within three months of surgery
- History of chronic oral corticosteroid use
- History or current drug or alcohol abuse
- In the surgeon's opinion, the subject will be non-compliant with the study protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University — St Louis
Identifiers
NCT: NCT07226388 · 202501233